NCT04058821

Brief Summary

The aims are:

  1. 1.Investigate new magnetic resonance imaging (MRI) scans for diagnosing severe nerve injury in the arm.
  2. 2.Understand how the brain and spinal cord respond to severe nerve injury using MRI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 14, 2019

Last Update Submit

August 14, 2019

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus

    diagnostic accuracy of diffusion tensor MRI for detecting any root avulsion of the brachial plexus

    7 mins

Study Arms (1)

Adults with traumatic brachial plexus injuries

EXPERIMENTAL

Participants will have two MRI scans before surgery (to find out the best time to scan), then two after surgery (at 6 and 12 months).

Diagnostic Test: Novel MRI scan - 7 days post injuryDiagnostic Test: Novel MRI scan - 14 days post injuryDiagnostic Test: Functional MRI scan - 6 months post brachial plexus explorationDiagnostic Test: Functional MRI scan - 12 months post brachial plexus exploration

Interventions

Novel MRI scan - 7 days post injuryDIAGNOSTIC_TEST

* A turbo spin-echo localiser (20 seconds) * Single-shot echo planar diffusion tensor imaging (7 minutes) * 3D constructive interference in steady state (CISS, 6 minutes) * Phase-sensitive inversion-recovery gradient echo with cardiac gating (4 minutes)

Adults with traumatic brachial plexus injuries
Novel MRI scan - 14 days post injuryDIAGNOSTIC_TEST

* A turbo spin-echo localiser (20 seconds) * Single-shot echo planar diffusion tensor imaging (7 minutes) * 3D constructive interference in steady state (CISS, 6 minutes) * Phase-sensitive inversion-recovery gradient echo with cardiac gating (4 minutes)

Adults with traumatic brachial plexus injuries
Functional MRI scan - 6 months post brachial plexus explorationDIAGNOSTIC_TEST

* Continuous whole brain echo-planar imaging * High-resolution T1-weighted imaging of the brain * Bilateral magnetic resonance spectroscopy (12 minutes)

Adults with traumatic brachial plexus injuries
Functional MRI scan - 12 months post brachial plexus explorationDIAGNOSTIC_TEST

* Continuous whole brain echo-planar imaging * High-resolution T1-weighted imaging of the brain * Bilateral magnetic resonance spectroscopy (12 minutes)

Adults with traumatic brachial plexus injuries

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with traumatic BPIs who require surgical exploration of the supraclavicular brachial plexus. A traumatic BPI is defined by the absence of any or all motor or sensory function in an upper limb, following trauma.

You may not qualify if:

  • Patients with an acutely ischaemic limb as they require immediate surgical intervention
  • Unable to get into the MRI scanner due to habitus or claustrophobia
  • Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)
  • Intraocular or intracranial metallic foreign bodies
  • Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve stimulators, etc) which are not MRI safe or conditional.
  • Pregnancy - whilst there are no known adverse effects of MRI(129-131) to the mother or fetus, MRI is generally avoided in pregnancy due to the acoustic trauma(132) and inductive heating generated by alternating magnetic fields.
  • Any pre-existing neurological disorder, injury or disease causing a functional impairment in the affected limb
  • Patients lacking capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James's University Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Ryckie Wade

CONTACT

0113 392 3355ryckiewade@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 16, 2019

Study Start

January 29, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

GB(1)